Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)
研究概览
简要总结
The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.
详细描述
High-risk patients undergoing cardiac surgery are at high risk for myocardial ischemia, arrhythmia, cardiogenic shock and other clinical complications. Different therapeutic options are available to support these patients in the perioperative period including inotropes, vasopressors, and vasodilators, and also assist devices such as intra-aortic balloon pump (IABP) and others.
IABP increases myocardial oxygen supply by increasing diastolic coronary perfusion pressure and decreases myocardial oxygen demand by reducing left ventricular afterload. Additionally, IABP can also improve cardiac output and systemic perfusion. The hypothesis of this randomized and controlled trial is that the placement of IABP immediately before the cardiac surgery reduces clinical complications in high-risk patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or higher than 18 years old
- •EuroSCORE equal to or higher than 6 or ejection fraction equal to or lower than 40%
- •Written informed consent
排除标准
- •Cardiogenic shock
- •Acute myocardial infarction (AMI) < 48 hours
- •Mechanical complications of AMI
- •Peripheral vascular disease (aorta, iliac or femoral)
- •Severe aortic regurgitation
- •Pregnancy
- •Tachyarrhythmia
- •Procedures of the aorta
- •Coagulopathy
- •Thrombocytopenia
- •Cardiac transplantation, congenital heart disease or endocarditis
- •Refusal to consent
结局指标
主要结局
Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)
时间窗: 30 days
Composite outcome of 30-day mortality or incidence of patients presenting a major complication according to modified Society of Thoracic Surgeons (STS): mechanical ventilation \> 24 hours, deep sternal wound infection/mediastinitis, surgical reexploration, stroke, cardiogenic shock and acute renal failure.
次要结局
- Evaluation of hemodynamic data(48 hours)
- Delirium(30 days)
- Bleeding(24 hours)
- Duration of mechanical ventilation(30 days)
- IABP complications(30 days)
- Use of vasoactive agents(30 days)
- Levels of biomarkers(7 days)
- Echocardiographic parameters(7 days)
- Costs(30 days)
- 30-day mortality(30 days)
- 60-days mortality(60 days)
- 1-year mortality(1 year)
- Acute Kidney Injury(30 days)
- Cardiovascular complications(30 days)
- Infectious complications(30 days)
研究者
Ludhmila Abrahão Hajjar
Professor of Cardiology, University of Sao Paulo
University of Sao Paulo